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CGMP Violations in Tentamus India Inspection

[ Price : $8.95]

FDA warns Indias Tentamus India Private Limited contract laboratory about significant violations of CGMP regulations.

Advita Ortho Hit with 7 QS Violations

[ Price : $8.95]

FDA warns Exactech, doing business as Advita Ortho, about Quality System violations in its production of accessories for the Equin...

Rosemont Pharma Gets Complete Response on Valacyclovir

[ Price : $8.95]

FDA posts a 3/5 complete response letter to Rosemont Pharmaceuticals, rejecting the companys NDA for valacyclovir.

CGMP Issues at Simtra BioPharma Solutions

[ Price : $8.95]

FDA warns Westphalia, Germany-based Simtra BioPharma Solutions about CGMP violations in its manufacturing of finished drugs.

Novo Nordisk PADE Reporting Violations

[ Price : $8.95]

FDA warns Novo Nordisk in Plainsboro, NJ, about its failure to meet postmarketing adverse drug experience reporting requirements.

CGMP Violations at Fareva Morton Grove

[ Price : $8.95]

FDA warns Frances Fareva about CGMP violations in the production of finished drugs at its Morton Grove, IL, manufacturing facility...

FDA Issues Early Alert on Erbe Flexible Cryoprobes

[ Price : $8.95]

FDA issues an early alert regarding a potential safety issue with certain Erbe USA Flexible Cryoprobes, following reports that som...

Hims & Hers Super Bowl Ad Hit

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The Institute for Safe Medicines calls on FDA, the Federal Trade Commission, and the Department of Justice to take enforcement act...

FDA DTC Ad Crackdown Raises Legal Issues: Attorneys

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Five Sidley attorneys recommend ways in which drug companies can analyze their direct-to-consumer promotions to see if they are li...

FDA Flags Safety Reporting Lapses at U.K. Clinical Trial Site

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FDA cites a U.K.-based clinical research center for failing to promptly report adverse events and for potential falsification of s...